REVERT - taRgeted thErapy for adVanced colorEctal canceR paTients

NCT05396807 | Completed

• 1 other identifier: University Tor Vergata
• Study Type: interventional
• Target: 106
• Locations: 3 countries
• Sites: 6

Brief Summary

This is a clinical prospective, no-Profit, Interventional, Premarket Medical Device "early phase", multicentre, single-arm study, based on collecting data on predictive biomarkers of mCRC patients, integrate them with the results of the retrospective evaluation of outcomes and profiles of historical mCRC patients previously treated in the Oncology Units, in order to evaluate the efficacy of the best administered treatment. Results from the retrospective evaluation, will serve to build an AI-based profile capable to identify "good" or "poor" responders to therapy and to support the clinician towards the best treatment option. AI is a software based on algorithm defined as Medical Device Class IIa.

Conditions

Metastatic Colon Cancer

Keywords

metastatic Colon Rectal Cancer; WT wild type; RAS

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Progression Free Survival (PFS), including PFS1 and PFS2, defined as the time from enrolment to the first documentation of objective disease progression or death due to any cause, whichever occurs first.

  through study completion, an average of 1 year

Secondary Outcomes (4)

• Overall survival (OS)

  through study completion, an average of 1 year

• Response Rate (RR)

  through study completion, an average of 1 year

• Early Tumour Shrinkage (ETS)

  through study completion, an average of 1 year

• Quality of Life (QoL)

  through study completion, an average of 1 year

Study Arms (1)

All subjects

OTHER

mCRC subjects with WT (wild type) and RAS (matated)

Device: AI

Interventions

AI DEVICE

The aim of using AI software to support physicians in choosing the most effective treatment.

All subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated Informed Consent.
• Age ≥ 18 years at time of Informed Consent.
• Histologically- or cytologically-confirmed mCRC.
• Assessed tumour EGFR pathway mutational status (K-RAS, N-RAS), BRAF, HER-2 neu, MSI.
• Sufficient amount of representative tumour specimen (primary or metastatic, archival or newly obtained for confirmatory central laboratory testing of BRAF and KRAS mutational status.
• Dihydropyrimidine dehydrogenase (DPD) before 5-FU infusion.
• Eligibility to receive bevacizumab, cetuximab or panitumumab per locally approved label with regard to tumour RAS status.
• Recurrence of disease after primary radical surgery and adjuvant therapy carried out \> 6 months prior the present trial.
• Evidence of measurable or evaluable non-measurable disease as per RECIST, v1.1
• ECOG PS of 0 or 1.
• Adequate bone marrow function characterized by the following at screening:
• Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L;
• Platelets ≥ 100 × 10\^9/L;
• Haemoglobin ≥ 9.0 g/dL.
• Adequate renal function characterized by serum creatinine ≤ 1.5 × upper limit of normal (ULN), or creatinine clearance ≥ 50 mL/min.

You may not qualify if:

• Prior hypersensitivity or toxicity to chemotherapy drugs suggesting an inability to tolerate the proposed treatment.
• Patients should not be candidate for upfront resection of metastatic disease.
• Symptomatic brain metastasis.
• Leptomeningeal disease.
• Known history of acute or chronic pancreatitis.
• History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery).
• Impaired cardiovascular function or clinically significant cardiovascular diseases.
• Uncontrolled hypertension defined as persistent elevation of systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite current therapy.
• Impaired hepatic function, defined as Child-Pugh class B or C.
• Concurrent or previous other malignancy.
• History of thromboembolic or cerebrovascular events ≤ 6 months prior to starting study treatment.
• Concurrent neuromuscular disorder associated with elevated CK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
• Known contraindication to receive antineoplastic treatment at the planned doses.
• Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient an inappropriate candidate for the study.
• Pregnancy, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test result, or lactating.

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (6)

Scienze della Salute Università degli Studi di Firenze

Florence, 50121, Italy

Location

Unità Oncologia Medica Dipartimento di Discipline Chirurgiche, Oncologiche e Stomatologiche

Palermo, 90127, Italy

Location

Medical Oncology Unit, Department of Oncohematology, Policlinico Tor Vergata

Roma, 00133, Italy

Location

"Grigore T. Popa" University of Medicine and Pharmacy of Iași

Iași, Iaşi, 700115, Romania

Location

Regional Institute of Oncology

Iași, Iaşi, 700483, Romania

Location

Hospital General Universitario Santa Lucía

Cartagena, Murcia, 30202, Spain

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Mario Roselli, PI

  Medical Oncology Unit, Department of Oncohematology, Policlinico Tor Vergata

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, Head of the Oncology Unit

Model Details: Patients, male and female, age ≥18 years, with WT (wild type) and RAS mutated (mut) affected by mCRC.

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 31, 2022
• Study Start: March 21, 2023
• Primary Completion: March 31, 2024
• Study Completion: November 25, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

IT (3); RO (2); ES (1)